Gcp Quality Event Assessment and Investigation Lead
2 weeks ago
**Job Description**:
- ROLE SUMMARY- You will assess and categorize submitted GCP Quality Events (QEs) to determine if the Significant Quality Event (SQE) threshold has been met or manage a confirmed SQE case through the investigation process including root cause analysis. You will ensure submitted QEs are assessed promptly and the investigations are conducted thoroughly, within required timelines and to compliance including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. You will lead the SQE team in the development of appropriate Corrective and Preventative Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to completion.- KEY RESPONSIBILITIES-
- Ensure that each submitted QE is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified, enabling expedited investigation where necessary.
- Ensure that each confirmed SQE is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done prior to investigation to allow for the appropriate analysis and quality outcome. ll including a well written case summary (that meets defined quality standards) which can be used in a regulatory inspection.
- Ensure that case documentation is complete and accurate and filed as necessary in the appropriate repository to ensure inspection readiness.
- Escalate concerns, as appropriate, regarding the progress of a case so that it can be addressed and resolved in a timely manner.
- Manage all extension requests for cases, actions and CAPA effectiveness checks so that approvers are given adequate time to approve prior to an overdue notification.- BASIC QUALIFICATIONS-
- Bachelor degree and a minimum of 10 years related experience in a pharmaceutical environment including experience in data management, GCP Quality, GxP Quality, and/or regulatory, or
- Masters degree and a minimum of 5 years related experience in a pharmaceutical environment including experience in data management, GCP Quality, GxP Quality, and/or regulatory inspection
- Experience leading and coordinating a cross-functional/matrix team, managing to timelines
- Detailed knowledge of clinical trial processes and relationships
- Knowledge of GCP requirements and applicable SOPs and regulations
- Proficiency with Microsoft Office
- Strong written and verbal communication skills- PREFERRED QUALIFICATIONS-
- Experience with a continuous improvement DMAIC methodology (e.g., Lean Six Sigma)-
- Pfizer encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Pfizer will accommodate the needs of applicants with disabilities throughout all stages of the selection process. Should accommodation during the recruitment process be required, please advise your Talent Acquisition representative.
- Quality Assurance and Control
LI-PFE
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